Properties
What is it?
Composition: Composition of lozenge: Active substance: Dequalinium chloride 0.25 mg, Dibucaine hydrochloride 0.03 mg. Excipients: Sorbitol, Magnesium stearate, Talc, Colloidal anhydrous silica, Flavor "Garden Mint", Garden mint oil. Indications for use: Local treatment of inflammatory diseases of the oral cavity and pharynx (including stomatitis, gingivitis) accompanied by pain syndrome and/or aphthae. Method of administration and dosage: Tablets should be dissolved in the oral cavity. Tablets are dissolved slowly, without chewing. The duration of the treatment course is determined by the doctor individually. For adults and children over 12 years of age, 1 tablet is prescribed every 2 hours, after reduction of inflammation symptoms – 1 tablet every 4 hours. For children over 4 years of age – 1 tablet every 3 hours, after reduction of inflammation symptoms – 1 tablet every 4 hours. The patient should consult a doctor if symptoms do not disappear or the condition worsens after 7 days of treatment with the preparation. Contraindications: Hypersensitivity to any component of the preparation; known allergy to quaternary ammonium compounds (e.g., benzalkonium chloride). Adverse reactions: Rarely – hypersensitivity reactions; very rarely – rash and allergic reactions accompanied by itching. From the respiratory, thoracic and mediastinal organs: frequency unknown – dyspnea. Special instructions: The preparation does not contain sugar, therefore it can be used by individuals with diabetes mellitus. The preparation contains sorbitol, therefore its use should be avoided in patients with rare hereditary diseases such as fructose intolerance syndrome. Effect on the ability to drive vehicles and operate machinery: No studies have been conducted on the effect of the medication on the ability to drive vehicles and operate machinery requiring increased speed of psychomotor reactions. However, the probability that the preparation has a negative impact on the mentioned functions is unlikely. Use during pregnancy and lactation: Controlled studies on the use of the preparation during pregnancy have not been conducted. Due to this situation, the preparation Debara is used during pregnancy only after consulting a doctor, if the therapeutic effect outweighs the possible risk to the fetus. Clinical studies on the penetration of active substances into breast milk have not been conducted. Use of the preparation during lactation is not recommended. Use in pediatrics: The preparation in the given dosage form is not prescribed for children under 4 years of age. Interaction with other medicinal products: The effectiveness of the preparation is reduced when used with anionic surfactants contained in ordinary toothpaste. Therefore, after cleaning teeth, the preparation Debara can be used after at least half an hour has passed. Overdose: This combination is usually well tolerated. However, the following symptoms may develop: dizziness, vomiting, esophageal irritation. Treatment: symptomatic. Gastric lavage and induction of vomiting should be avoided. Dosage form: Lozenges. 10 tablets in a blister. 2 blisters with instructions for use in a cardboard box. Storage conditions: Store at a temperature not exceeding 25C, out of reach of children! Shelf life: 3 years from the date of manufacture, do not use after the expiry date. Pharmacy dispensing rule: Pharmaceutical product group III, dispensed without a prescription